Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent / Metastatic Cervical Cancer in Italy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Locally Advanced Cervical Cancer, Recurrent Cervical Cancer, Metastatic Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent / Metastatic (R/M) Cervical Cancer in Italy
Overview
Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.
Detailed description
This is a multicenter, observational, retrospective study. The primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (R/M and LACC) in Italy, through a retrospective data capture, from January 2018 to December 2021.
Eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic).
Disease will be defined as follow:
* Locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2B, 3 and 4A (FIGO staging) * Recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26) * Metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4B (FIGO staging) Moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.
Primary outcome measures
- The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%) [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
- The proportion of patient with recurrence or dead after treatment and remission (%) [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
- Median time from remission to recurrence [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
- Number of lines of treatment [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
- The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
Secondary outcome measures (4)
- The proportion of patients who undergone screening program (%) [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
- HPV subtype typization, if available [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
- History of HPV related lesions (CIN 2+ lesion) [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
- The proportion of patients with PD-L1 >1% and >50% (%) [Time frame: Retrospective data capture from Jan 2018 to Dec 2021]
Eligibility criteria
Inclusion criteria
- Patient (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF)
- Age ≥18 years
- Diagnosis of a cervical cancer
- Locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease
- Any treatment received between January 2018 and December 2021 for advanced disease
Exclusion criteria
- Patients participating in a pharmacological clinical trial for the treatment of advanced disease
- Patients who participated in a clinical trial
- Patients who were administered with Pembrolizumab, Olaparib or Levantinib or medications from these class of drugs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 11 centers
- Oncologia Medica Policlinico Sant'Orsola Malpighi — Bologna
- Ginecologia ed Ostetricia A.O. Cannizzaro — Catania
- Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino — Genova
- Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele — Milan
- Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X — Milan
- Oncologia A.O.U. di Modena - Policlinico — Modena
- U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pa — Naples
- UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli — Naples
- … and 3 more centers
Identifiers
NCT: NCT06771193 · NIS102062